Device Listing 1437676988

Listing Summary#

Listing key: 1437676988
Premarket submission: K972041
Device: EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
Applicant: Sigma Diagnostics, Inc.
Product code: LBS
Decision date: 1997-07-22

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
16364	1318354	1318354	Trinity Biotech USA	1	Y	2026-01-01	2823 Girts Rd Jamestown NY US 14701